Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
Reported: December 7, 2016 Initiated: October 31, 2016 #Z-0663-2017
Product Description
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
Reason for Recall
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Details
- Recalling Firm
- Spectranetics Corporation
- Units Affected
- 873 units
- Distribution
- Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
- Location
- Colorado Springs, CO
Frequently Asked Questions
What product was recalled? ▼
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.. Recalled by Spectranetics Corporation. Units affected: 873 units.
Why was this product recalled? ▼
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0663-2017.
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